(66 days)
Not Found
No
The summary describes a mechanical cranial drill and its accessories, with performance studies focused on mechanical properties and user handling. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
A therapeutic device is used to treat or cure a disease or medical condition. This device is a surgical drill used to create access through the skull for diagnostic procedures (biopsy) or for placing catheters, but it does not treat or cure a condition itself.
No
The device, a cranial drill, is used to create access through the skull for surgical procedures (e.g., ventriculostomy, biopsy, catheter placement). It is an interventional/surgical tool, not a diagnostic one.
No
The device description explicitly states it is composed of a "MR Compatible Hand Drill and Drill Bit Kits," which are physical hardware components. The performance studies also focus on the mechanical performance of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide access through the skull for surgical procedures (ventriculostomy, biopsy, catheter placement). This is a surgical tool used directly on the patient's body.
- Device Description: The device is a drill and drill bits, which are mechanical instruments for surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
Therefore, the MRII Cranial Drill and Accessories are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MRII Cranial Drill and Accessories are intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum strength. The MRII Cranial Drill and Accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HBG
Device Description
The MRII Cranial Drill and accessories is composed of the MR Compatible Hand Drill and Drill Bit Kits, packaged separately and found substantially equivalent in K 122456. The packaging is identical to that of the predicate device. The MRII Cranial Drill is wrapped in CSR and then sealed in a Tyvek pouch. The Drill Bit Kits are packaged in a sealed tray within a sealed Tyvek pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OR or MRI Suite
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The modifications of the MRII Cranial Drill and 3.2mm Drill Kit were conducted in conformance with the company's design control procedures. Design inputs provided the requirements for the respective product specifications. Design Verification was performed relative to these specifications with acceptable results. Risk analysis was performed with mitigation of all identified risks to acceptable levels. The tests and risk analysis demonstrated that the modified MRII Cranial Drill and 3.2mm Drill Kit functions as intended and is substantially equivalent to the legally marketed MRII Cranial Drill and accessories.
Drilling Efficiency, Smooth Operation, and Vibration during Drilling:
- Test Method Summary: To evaluate the Drilling Efficiency, smooth operation, and vibration during drilling, of the MRI Hand Drill. A block of sawbones with a hardness of 65D was used as the simulated skull material. Simulated scalp material was placed on top of the Sawbones block. The sample was clamped with a table vice, and placed on a weight scale. The Hand Drills were used to drill holes through the simulation material, using a drill speed of 1 handle turn per second, for each trial. 3.2, 4.5, and 6.0 mm Drill bits were used with each Hand Drill Tested.
- Acceptance Criteria: Drilling Efficiency: Drill through simulated material in under 1 minute. Smooth Operation and Vibration During Drilling: User evaluation score of 3.0 (scale of 1.0 - 5.0) or higher.
- Results: All modified MRI Hand Drills met the acceptance criteria. All Hand Drills were able to drill through the simulated material in under a minute and received user evaluation scores greater than 3.0 for both smooth operation and vibration during drilling. This was substantially equivalent to the predicate Hand Drill.
Drill Bit Retention under Axial Loading, Drill Bit Loading, and Handling with Wet Gloves:
- Test Method Summary: Purpose: To determine how well the Hand Drills' Chuck grips the Drill Bit, when an axial loading is applied to the Drill Bit. A Drill Bit was attached to the MRI Hand Drills, using wet gloves; The Drill Bit was not fully seated inside the Chuck, to allow for it to slip in compression. Then, the Drill was clamped to the table, using a table vice and clamping directly on the Drill, such that the Drill Bit hangs freely. A Force Gauge was then attached to the Drill Bit, to administer a 5.0 lbf minimum compression load, and see if Drill Bit would slip further into the Chuck. Afterwards, The Force Gauge was used to pull on the Drill Bit, to administer a 5.0 lbf minimum force, and see if the Drill Bit would slip out of the Chuck in tension. Marks were made on the drill bits to measure the slippage based on the before and after measurements. This test was performed for the 3.2 and 4.5 mm Drill Bits with the Tri-flat geometry.
- Acceptance Criteria: Drill Bit Retention Under Axial Loading: 0 mm slippage under a 5.0 lbf minimum force. Drill Bit Loading, Wet Glove Usage: a user evaluation score of 3.0 (scale of 1.0 - 5.0) or higher.
- Results: All modified MRI Hand Drills met the acceptance criteria. None of the modified Hand Drills had any slippage when a minimum axial load of 5.0 lbf was applied in both tension and compression directions. The Drill Bit Loading and Wet Glove usage requirements both scored higher than 3.0 for all modified Hand Drills tested. This was substantially equivalent to the predicate Hand Drill.
Drill Bit Retention under Torque Loading, Drill Bit Loading, and Handling with Wet Gloves:
- Test Method Summary: Purpose: To determine how well the Hand Drills' Chuck grips the Drill Bit, when Torque is applied to the Drill Bit. A Drill Bit was attached to each MRI Hand Drill, using wet gloves. Then, the Drills were clamped to the table, using a table vice. A Torque Gauge was attached to the opposite end of the drill bit. A Torque was then applied to the drill, to see if there was any noticeable slip. Alignment marks where made of the Drill Bit and Chuck Housing, to see if there was any misalignment after applying the torque. This test was performed for the 3.2 and the 4.5 mm Drill Bits with Tri-flat geometry.
- Acceptance Criteria: Drill Bit Retention Under Torque: No movement of the Drill Bit inside the Chuck Housing, when a Torque is applied to the Drill Bit. Drill Bit Loading, Wet Glove Usage: a user evaluation score of 3.0 (scale of 1.0 - 5.0) or higher.
- Results: All modified MRI Hand Drills met the acceptance criteria. None of the modified Hand Drills had any slippage when a minimum torque 10 in-lbf was applied to the Drill Bits. The Drill Bit Loading and Wet Glove usage requirements both scored higher than 3.0 for all modified Hand Drills tested. This was substantially equivalent to the predicate Hand Drill.
MRI Hand Drill and Drill Bit Run-out Testing (new comparative test):
- Test Method Summary: Purpose: To measure the amount of Run-out in the Hand Drill/Drill Bit assembly, when the drill is rotating. The Hand Drill Body was clamped in a table vice, such that the Hand Drill could still spin freely. A Drill Bit was attached to the Drill. A deflection gauge was placed at different point on the drill; on the Shaft Coupler, The Chuck Housing, on the Drill Bit near the Chuck Housing. The Drills were then turned, to see how much "wobble" was measured at each point. This was repeated for.
- Acceptance Criteria: The modified Hand Drill shows a reduction in the amount of Run out in the Drill and Drill Bit.
- Results: All modified Hand Drills had approximately a 50% reduction in the amount of run-out (unwanted movement). This improvement does not change the use, safety or effectiveness of the Hand Drill.
MRI Hand Drill Shaft Deflection Test (new comparative test):
- Test Method Summary: Purpose: To measure the amount of deflection in the Shaft, when a side load is applied to the Chuck Housing. The hand Drill Body is clamped into a table vice. A force gauge is used to apply a 5 lbf side loading onto the Chuck Housing. The amount of deflection of the Housing is measured with a deflection gauge.
- Acceptance Criteria: The modified MRI Hand Drills show a reduction in the amount of deflection in the shaft when a side load is applied to the Chuck assembly.
- Results: All modified MRI Hand Drills had a reduction in the amount of deflection by approximately 60%, compared to the PEEK shafts of the predicate Hand Drill. This improvement does not change the use, safety or effectiveness of the Hand Drill.
Chuck Housing Lock Washer Break Force Test (new test; this test was not performed on predicate devices, since predicates does not have this feature):
- Test Method Summary: Purpose: To characterize the strength of the Loctite bond between the Chuck Housing and Lock Washer. Chucks were loosened fully on Hand Drills. Drill Bodies were clamped to a Table Vice. A clamp was attached to the Chuck Housing, which was connected to the Force Gauge. The Force gauge was used to pull on the Chuck Housing axially, until the bond between the Lock Washer and Chuck Housing broke. The break force was then measured.
- Acceptance Criteria: The Lock Washers shall have a minimum break force of 5 lbf.
- Results: All modified Hand Drills had a Lock Washer break force greater than 5.0 lbf. Predicate Hand Drills have not undergone this test, since they do not have a Lock Washer feature. This modification does not change the use, safety or effectiveness of the Hand Drill.
Chuck Tightening Torque vs. Chuck Insert Slip Torque (new comparative test developed when the New Pinned Chuck Insert design was introduced):
- Test Method Summary: Purpose: The Chuck Insert's slip torque was measured at different tightening torques of the Chuck Housing. This was done to see how well the new cross pin feature inside the Insert prevents the Chuck Insert from spinning inside the Chuck Housing. Set-up: Each Chuck/Shaft sub-assembly was removed from each Hand Drill Gear Housing. A Drill Bit was
- Results: The modified Hand Drill design did not slip at any level of Chuck tightening torque. The predicate Hand Drill Chuck Insert slip torque is approximately equal to the Chuck Housing's tightening torque. The user no longer has to tighten the chuck on the modified Hand Drill beyond what it takes to hold the drill bit. This modification does not change the use, safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories
(a)
Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, graphic style, with bold lines and a sense of movement. The overall design is clean and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2016
MRI Interventions, Inc. Mr. Peter Piferi Chief Operating Officer 5 Musick Irvine, California 92618
Re: K160129
Trade/Device Name: MRII Cranial Drill and Accessories Regulation Number: 21 CFR 882.4300 Regulation Name: Manual Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBG Dated: February 25, 2016 Received: February 25, 2016
Dear Mr. Peter Piferi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -SD/A
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160129
Device Name MRII Cranial Drill and Accessories
Indications for Use (Describe)
The MRII Cranial Drill and Accessories are intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum strength. The MRII Cranial Drill and Accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the MRII Cranial Drill and Accessories.
Company Making the Submission: 1.
| Name of Owner: | MRI Interventions, Inc. |
|---|---|
| Address: | 5 Musick |
| Irvine, CA 92618 | |
| Telephone: | 949-900-6833 |
| Fax: | 949-900-6834 |
| Contact: | Peter Piferi |
| E-mail: | ppiferi@mriinterventions.com |
2. Date Prepared:
January 12th, 2016
Device Name: 3.
| Common Name: | Manual Drill |
|---|---|
| Proprietary Name: | MRII Cranial Drill and |
| Accessories | |
| Classification: | II |
| Regulation Number: | 21CFR 882.4300 |
| Product Code: | HBG |
4. Predicate Device:
MRII Cranial Drill and Accessories, K122456 SmartTwist MRII Hand Drill, SmartTip MRII Drill Bit Kit, 4.5mm, 6.0mm, K151536
5. Device Description:
The MRII Cranial Drill and accessories is composed of the MR Compatible Hand Drill and Drill Bit Kits, packaged separately and found substantially equivalent in K 122456. The packaging is identical to that of the predicate device. The MRII Cranial Drill is wrapped in CSR and then sealed in a Tyvek pouch. The Drill Bit Kits are packaged in a sealed tray within a sealed Tyvek pouch.
6. Indications for Use
The MRII Cranial Drill and Accessories are intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or
4
catheter placement, in or near an MR scanner of 3T maximum strength. The MRII Cranial Drill and Accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.
7. Summary of the Technological Characteristics of the Device Compared to the Predicate Device:
Modifications of the predicate MRII Cranial Drill and accessories are:
a) Changing the drill shaft material from PEEK to anodized aluminum
b) Changing the drill chuck housing material from PEEK to Delrin and adding a locking pin and slot
c) Shortening the slots on the chuck insert
d) Adding a shoulder feature to the drill chuck housing
e) Changing the shaft coupler material from PEEK to Delrin and adding a shoulder feature
f) Adding a lock washer to the back of the chuck housing
g) Adding a PTFE spacer between the pinion gear and drill housing
h) Modifying the proximal end of the 3.2-mm Drill Bit from a round shank with one flat to a round shank with three flats. This is an identical design that was reviewed and cleared under K151536.
The MRII Cranial Drill and 3.2mm Drill Bit shank modifications are part of continuous product improvement efforts. These minor changes make insertion of the Drill Bits and tightening of the Drill Chuck easier. These modifications will also allow the drill to rotate smoother with less run out.
| | MRII Hand Drill and
Accessories with minor design
modifications | Predicate Device
MRII Hand Drill and
Accessories
K151536 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 882.4300 | 21 CFR 882.4300 |
| Product Code | HBG | HBG |
| Intended Use | The MRII Cranial Drill and
accessories are intended to
provide access through the skull
for ventriculostomy or other
neurological procedures, such
as biopsy or catheter placement,
in or near an MR scanner of 3T
maximum strength. The MRII
Cranial Drill and accessories are
intended to be used only when
the scanner is not performing a
scan. The MRII Cranial Drill is
intended for single use only. | The MRII Cranial Drill and
accessories are intended to
provide access through the skull
for ventriculostomy or other
neurological procedures, such
as biopsy or catheter placement,
in or near an MR scanner of 3T
maximum strength. The MRII
Cranial Drill and accessories are
intended to be used only when
the scanner is not performing a
scan. The MRII Cranial Drill is
intended for single use only |
| Environment | OR or MRI Suite | OR or MRI Suite |
5
| Sterilization | EO 10^-6 SAL | EO 10^-6 SAL |
|---|---|---|
| Hand Drill Shaft | ||
| (non patient contacting, minor change to reduce run out, performs same function) | O.D: .245 in | |
| Length: 3.97 in | ||
| Material: Anodized Al 6061 | O.D: .240 in | |
| Length: 3.80 in | ||
| Material: PEEK | ||
| Washer | ||
| (non patient contacting, minor change to capture shaft coupler) | I.D: .435 in | |
| O.D: .625 in | ||
| Thickness: .031 in | ||
| Material: Nylon | N/A | |
| Gear Housing Inner Lip Depth | ||
| (minor dimension change to reduce play) | .060 in | .090 in |
| Dowel Pin | ||
| (non patient contacting, minor change to prevent slipping) | O.D: .063 in | |
| Length: .313 in | ||
| Material: 316 SS | N/A | |
| Chuck Insert (minor dimension change to improve drill bit engagement) | Tri-Slot Length: .525 in | |
| Cross Pin Hole Dia: .063 in | Tri-Slot Length: .820 in | |
| Cross Pin Hole Dia: N/A | ||
| Drill Shaft Coupler | ||
| (non patient contacting, minor dimensional changes and to accept pin and washer) | O.D: .468 in | |
| Length: 1.12 in | ||
| Cross Pin Slot; Dia: .078 in, Length: .273 | ||
| Lock Washer Step; Dia: .425 in, Length .506 in | ||
| Drill Shaft Pilot Hole; Dia: .246 in, Depth: .225 in Material: Delrin | O.D: .500 in | |
| Length: .90 in | ||
| Cross Pin Slot; N/A | ||
| Lock Washer Step; N/A | ||
| Drill Shaft Pilot Hole; N/A | ||
| Material: PEEK | ||
| Drill Chuck Housing | ||
| (non patient contacting, minor dimensional changes to improve assembly, accept washer and improve ergonomics) | Length: 1.57 in | |
| Lock Washer Seat; Dia: .642 in, Depth: .040 | ||
| Shaft Coupler Pilot Hole; Dia: .469 in, Depth .66 in | ||
| Material: Delrin | Length: 1.16 in | |
| Lock Washer Seat: N/A | ||
| Shaft Coupler Pilot Hole: Dia: .547 in, Depth .25 in | ||
| Material: PEEK | ||
| Shim | ||
| (minor change to reduce play and friction) | I.D: .25 in | |
| O.D: .375 in | ||
| Thickness: .030 in | ||
| Material: Teflon | N/A | |
| Drill Bit Included with Drill | No | No |
6
| Drill Bit Sizes
(proximal shank
feature, minor change
to improve
engagement) | 3.2 mm (Tri Flat)
4.5 mm (Tri Flat)
6.0 mm (Tri Flat) | 3.2 mm (Single Flat)
4.5 mm (Tri Flat)
6.0 mm (Tri Flat) |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Drill Bit Material | 316L SST | 316L SST |
| Adjustable Depth
Guard | Yes | Yes |
| Packaging | Drill: Sterile, CSR Wrap in
Tyvek Peel Pouch
Kit: Sterile, inside tray with
Tyvek Lid and external Tyvek
Pouch | Drill: Sterile, CSR Wrap in
Tyvek Peel Pouch
Kit: Sterile, inside tray with
Tyvek Lid and external Tyvek
Pouch |
The modifications to the MRII Cranial drill and 3.2mm Drill Kit is substantially equivalent in intended use, technological characteristics and principles of operation to the predicate MRII Cranial Drill. Thus, the MRII Cranial Drill and 3.2mm Drill Kit modifications are substantially equivalent to the predicate.
8. Performance Data:
The modifications of the MRII Cranial Drill and 3.2mm Drill Kit were conducted in conformance with the company's design control procedures. Design inputs provided the requirements for the respective product specifications. Design Verification was performed relative to these specifications with acceptable results. Risk analysis was performed with mitigation of all identified risks to acceptable levels. The tests and risk analysis demonstrated that the modified MRII Cranial Drill and 3.2mm Drill Kit functions as intended and is substantially equivalent to the legally marketed MRII Cranial Drill and accessories.
Verification Testing Performance Summary Modified MRI Hand Drill (K160129) Compared to the Predicate MRI Hand Drill (K122456, K151536)
| Testing per VPR-0111 Rev A. | |||
|---|---|---|---|
| Test | Test Method Summary | Results | |
|---|---|---|---|
| Drilling Efficiency, Smooth | |||
| Operation, and Vibration | |||
| during Drilling | Purpose: To evaluate the | ||
| Drilling Efficiency, smooth | |||
| operation, and vibration | |||
| during drilling, of the MRI | |||
| Hand Drill. | All modified MRI Hand | ||
| Drills met the acceptance | |||
| criteria. All Hand Drills were | |||
| able to drill through the | |||
| simulated material in under a | |||
| minute and received user | |||
| evaluation scores greater than | |||
| 3.0 for both smooth operation | |||
| and vibration during drilling. | |||
| This was substantially | |||
| equivalent to the predicate | |||
| Set-up: A block of sawbones | |||
| with a hardness of 65D was | |||
| used as the simulated skull | |||
| material. Simulated scalp | |||
| material was placed on top of | |||
| the Sawbones block. The | |||
| sample was clamped with a | |||
| table vice, and placed on a | |||
| weight scale. The Hand Drills | |||
| were used to drill holes | |||
| through the simulation | |||
| material, using a drill speed | |||
| of 1 handle turn per second, | |||
| for each trial. 3.2, 4.5, and | |||
| 6.0 mm Drill bits were used | |||
| with each Hand Drill Tested. |
Acceptance Criteria:
Drilling Efficiency: Drill
through simulated material in
under 1 minute. Smooth
Operation and Vibration
During Drilling: User
evaluation score of 3.0 (scale
of 1.0 - 5.0) or higher. | Hand Drill. | |
| Drill Bit Retention under
Axial Loading, Drill Bit
Loading, and Handling with
Wet Gloves | Purpose: To determine how
well the Hand Drills' Chuck
grips the Drill Bit, when an
axial loading is applied to the
Drill Bit.
Set-up: A Drill Bit was
attached to the MRI Hand
Drills, using wet gloves; The
Drill Bit was not fully seated
inside the Chuck, to allow for
it to slip in compression.
Then, the Drill was clamped
to the table, using a table vice
and clamping directly on the
Drill, such that the Drill Bit
hangs freely. A Force Gauge
was then attached to the Drill
Bit, to administer a 5.0 lbf
minimum compression load,
and see if Drill Bit would slip
further into the Chuck.
Afterwards, The Force Gauge
was used to pull on the Drill
Bit, to administer a 5.0 lbf
minimum force, and see if the
Drill Bit would slip out of the | All modified MRI Hand
Drills met the acceptance
criteria. None of the modified
Hand Drills had any slippage
when a minimum axial load
of 5.0 lbf was applied in both
tension and compression
directions. The Drill Bit
Loading and Wet Glove
usage requirements both
scored higher than 3.0 for all
modified Hand Drills tested.
This was substantially
equivalent to the predicate
Hand Drill. | |
| | | | |
| Drill Bit Retention under
Torque Loading, Drill Bit
Loading, and Handling with
Wet Gloves | Chuck in tension. Marks
were made on the drill bits to
measure the slippage based
on the before and after
measurements. This test was
performed for the 3.2 and 4.5
mm Drill Bits with the Tri-
flat geometry.
Acceptance Criteria: Drill
Bit Retention Under Axial
Loading: 0 mm slippage
under a 5.0 lbf minimum
force. Drill Bit Loading, Wet
Glove Usage: a user
evaluation score of 3.0 (scale
of 1.0 - 5.0) or higher. | All modified MRI Hand
Drills met the acceptance
criteria. None of the modified
Hand Drills had any slippage
when a minimum torque 10
in-lbf was applied to the Drill
Bits. The Drill Bit Loading
and Wet Glove usage
requirements both scored
higher than 3.0 for all
modified Hand Drills tested.
This was substantially
equivalent to the predicate
Hand Drill. | |
| | Purpose: To determine how
well the Hand Drills' Chuck
grips the Drill Bit, when
Torque is applied to the Drill
Bit.
Set-up: A Drill Bit was
attached to each MRI Hand
Drill, using wet gloves. Then,
the Drills were clamped to
the table, using a table vice.
A Torque Gauge was
attached to the opposite end
of the drill bit. A Torque was
then applied to the drill, to
see if there was any
noticeable slip. Alignment
marks where made of the
Drill Bit and Chuck Housing,
to see if there was any
misalignment after applying
the torque. This test was
performed for the 3.2 and the
4.5 mm Drill Bits with Tri-
flat geometry.
Acceptance Criteria: Drill
Bit Retention Under Torque:
No movement of the Drill Bit
inside the Chuck Housing, | | |
| | | | |
| MRI Hand Drill and Drill Bit
Run-out Testing (new
comparative test) | when a Torque is applied to
the Drill Bit. Drill Bit
Loading, Wet Glove Usage: a
user evaluation score of 3.0
(scale of 1.0 - 5.0) or higher.
Purpose: To measure the
amount of Run-out in the
Hand Drill/Drill Bit
assembly, when the drill is
rotating.
Set-up: The Hand Drill Body
was clamped in a table vice,
such that the Hand Drill
could still spin freely. A Drill
Bit was attached to the Drill.
A deflection gauge was
placed at different point on
the drill; on the Shaft
Coupler, The Chuck
Housing, on the Drill Bit near
the Chuck Housing. The
Drills were then turned, to
see how much "wobble" was
measured at each point. This
was repeated for
Acceptance Criteria: The
modified Hand Drill shows a
reduction in the amount of
Run out in the Drill and Drill
Bit. | All modified Hand Drills had
approximately a 50%
reduction in the amount of
run-out (unwanted
movement). This
improvement does not
change the use, safety or
effectiveness of the Hand
Drill. | |
| MRI Hand Drill Shaft
Deflection Test (new
comparative test) | Purpose: To measure the
amount of deflection in the
Shaft, when a side load is
applied to the Chuck
Housing.
Set-up: The hand Drill Body
is clamped into a table vice.
A force gauge is used to
apply a 5 lbf side loading
onto the Chuck Housing. The
amount of deflection of the
Housing is measured with a
deflection gauge. | All modified MRI Hand
Drills had a reduction in the
amount of deflection by
approximately 60%,
compared to the PEEK shafts
of the predicate Hand Drill.
This improvement does not
change the use, safety or
effectiveness of the Hand
Drill. | |
| | | | |
| | Acceptance Criteria: The
modified MRI Hand Drills
show a reduction in the
amount of deflection in the
shaft when a side load is
applied to the Chuck
assembly. | | |
| Chuck Housing Lock Washer
Break Force Test (new test;
this test was not performed
on predicate devices, since
predicates does not have this
feature) | Purpose: To characterize the
strength of the Loctite bond
between the Chuck Housing
and Lock Washer.
Set-up: Chucks were
loosened fully on Hand
Drills. Drill Bodies were
clamped to a Table Vice. A
clamp was attached to the
Chuck Housing, which was
connected to the Force
Gauge. The Force gauge was
used to pull on the Chuck
Housing axially, until the
bond between the Lock
Washer and Chuck Housing
broke. The break force was
then measured.
Acceptance Criteria: The
Lock Washers shall have a
minimum break force of 5
lbf. | All modified Hand Drills had
a Lock Washer break force
greater than 5.0 lbf. Predicate
Hand Drills have not
undergone this test, since
they do not have a Lock
Washer feature. This
modification does not change
the use, safety or
effectiveness of the Hand
Drill. | |
| Chuck Tightening Torque vs.
Chuck Insert Slip Torque
(new comparative test
developed when the New
Pinned Chuck Insert design
was introduced) | Purpose: The Chuck Insert's
slip torque was measured at
different tightening torques
of the Chuck Housing. This
was done to see how well the
new cross pin feature inside
the Insert prevents the Chuck
Insert from spinning inside
the Chuck Housing.
Set-up: Each Chuck/Shaft
sub-assembly was removed
from each Hand Drill Gear
Housing. A Drill Bit was | The modified Hand Drill
design did not slip at any
level of Chuck tightening
torque. The predicate Hand
Drill Chuck Insert slip torque
is approximately equal to the
Chuck Housing's tightening
torque. The user no longer
has to tighten the chuck on
the modified Hand Drill
beyond what it takes to hold
the drill bit. This
modification does not change
the use, safety or | |
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9
10
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Summary of Risk Analysis
An FMEA was performed for the Hand Drill with modifications (FMEA-0063). The summary of the risk analysis is provided below. The following table is used for the O,S, and D rankings.
| Occurrence
(probability) | Detection (Chance of
detecting failure) | Severity (Clinical
Effect) | Non-Hazardous
Severity |
|------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| 1 - Low (1 in
400) | 1 - Detection is certain | 1 - Unnoticeable to
user. No effect on
performance. | 1 - No noticeable
delay/ no
dissatisfaction |
| 3 - Infrequent (1
in 200) | 2 – High probability of
detection | 3 - Minor impact to
patient. Minimal
impact to patient
baseline status | 3 - Minor delay/ slight
dissatisfaction |
| 5 - Periodic (1 in
100) | 4 - Detection
probability is moderate | 5 - Patient injury not
requiring treatment.
Alteration of patient's
clinical baseline
status | 5 - Noticeable delay/
statement of
dissatisfaction likely |
| 7 - High (1 in 50) | 6 - Detection
probability is low | 7 - Reversible patient
injury. Alteration of
patient's clinical
baseline status
requiring treatment | 7 - Prolonged delay/
dissatisfaction
communicated clearly |
| 10 - Very High
(1 in 25) | 8 – Slight probability of
detection | 8 – Irreversible
patient injury | 8 - Extensive delay /
extreme
dissatisfaction |
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| 10 - Detection almost | 10 - Death | 10 - Procedure |
|---|---|---|
| impossible | discontinued |
There were no items with residual RPN above 40. The highest severities (9) were for susceptibility to magnetic force or torque, as that could cause either loss of control or could cause the MRI Drill to be pulled into the scanner at high speed. However, this occurrence is essentially zero because the Drill is designed with non-ferromagnetic components. There are two cross-pins that are made out of 316L Stainless Steel. 316L has very low magnetic susceptibility, and the mass of the stainless steel pins is insignificant compared to the overall mass of the Hand Drill. The same 316L SST Pin is used in the predicate Hand Drill. Therefore, this risk is identical to the predicate Hand Drill.
The modified MRI Drill Shaft is also made out of anodized 6061 Aluminum. This modification to the Hand Drill did not increase any of the RPN's from the risk analysis performed on the predicate device.
The aluminum shaft has extremely low magnetic susceptibility (much lower than 316L SST), so it is unaffected by magnetic fields from 1.5T - 3.0T. So, the risk remained the same as the predicate Hand Drill.
The only new failure mode was the lock washer breaking off from the Chuck Housing. However, this has no clinical effect, and the occurrence is 1. The lock washer provides a benefit to the user since it prevents the Chuck Housing from falling off when the user loosens it. So the benefit of having the washer far outweighs the very minimal risk.
The modified Hand Drill also lowers the occurrence of two failure modes.
The Collet Jaws deforming during tightening the Chuck is now 1 (predicate device was 2), which lowers the RPN from 8 to 4.
The Chuck Housing does not have a good gripping surface for User to tighten adequately is now 1 (predicate device was 3), which lowers the RPN from 24 to 8.
All material changes from the predicate device are non patient contacting and do not provide any additional risk. The modified Hand Drill poses no additional challenge to sterilization over the predicate Hand Drill and therefore does not pose any additional risk.
The modifications to the Hand Drill do not increase the risks from the predicate Hand Drill.
The MRI Hand Drill is a safe alternative to power drills. It is still the case that the device operates at very low speed, and is manually powered. Both of these characteristics lead to a safe device in most cases. Most of the failures of the device occur toward the safe end-that is, the device does not spin or stops being usable, instead of failures that result in a loss of control. There were no new failure modes uncovered during testing that challenge the premise. In addition, most of the failure modes associated with the device are considered nonhazardous, as they do not result in any harm to the patient. The drill allows users to create small holes for interventional procedures in the MRI scanner. This is a great benefit to surgeons and patients, as it makes procedures faster and logistically easier. Therefore, the benefits of the device outweigh the risks.
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For the Drill Bit, there are also no new risks with the change to the shank geometry.
The Drill Bit had no material changes, so the highest severity items (FMEA-0064) remain unchanged:
Resistance Magnetic Force Displacement (RPN = 16, Severity = 8)
Drill made of non-biocompatible material (RPN = 80. Severity = 8) The change to the shank geometry does not add any new risks. As testing showed, it will only improve performance and allow users to exert less force to tighten the drill bit in the drill without slipping.
9. Consensus Standards:
The MRII Cranial Drill and accessories comply with the following recognized consensus standards:
- AAMI/ANSI/ISO 10993-1 Biological evaluation of medical devices Part ● 1: Evaluation and testing.
- . ANSI/AAMI/ISO 1135-1 Sterilization of health care - products - Ethylene oxide - Part 1: Requirements for development, validation, and routine control of sterilization process for medical devices
- ASTM F2052-05e1, Standard Test method for Measurement of ● Magnetically Induced Displacement Force on Medical Devcies in an MRI Environment.
10. Conclusion:
The modifications to the MRII Cranial Drill and 3.2mm Drill Kit were made in conformance with the company's design control procedures. Performance testing established the substantial equivalence of the modified MRII Cranial Drill and 3.2mm Drill Kit to the predicate MRII Cranial Drill and accessories, including design verification testing.
The MRII Cranial Drill has the same intended use and indications for use and similar technologies characteristics and principles of operation as the predicate Cranial Drill. The minor technological differences between the MRII Cranial Drill and accessories and its predicate raise no new issues of safety and effectiveness. Thus the modifications are substantially equivalent to the previously cleared MRII Cranial Drill and accessories.